Department of Clinical Biostatistics/Clinical Biostatistics CourseMedicine and Medical Science

Ph.D. Program-specific Professor Shiro Tanaka

Health technologies such as drugs should be assessed for efficacy and safety before applied to clinical practice through clinical trials, which require involvement of statisticians who have expertise in biostatistics. Clinical Biostatistics is a discipline on the statistical methodology in clinical trials such as study design and statistical analysis of clinical trial data.
Clinical Biostatistics Course is a course on biostatistics conducted by Department of Clinical Biostatistics and Department of Biostatistics. This course is intended for graduates from any fields, i.e. mathematics, physics, economics, life science and medicine. Medical knowledge is not a prerequisite.

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Research and Education

Clinical Biostatistics Course is a two-year Professional Degree Course (=master course) established in Kyoto University School of Public health (SPH). Master of Public Health (MPH [professional degree]) will be awarded in completing the course. This course provides students with, not only mandatory subjects such as basic statistics and clinical biostatistics classes, but also on-the-job training at Kyoto University Hospital and National Cerebral and Cardiovascular Center which gives students opportunities to experience the practice of academic clinical trials. This course is funded by the Japan Agency for Medical Research and Development (AMED).

Research and development

  1. Develop an educational program for Clinical Biostatistics Course
  2. Open attendance courses

    • Biostatistics for clinical researchers (seminars at hospitals)
    • Introduction to statistics for undergraduate students (E-learning contents for Open Course Ware )
  3. Statistical analysis of medical and health database
  4. Statistical methods for missing data in clinical trials

Recent Publications

  1. Takagi Y, Omori T. A statistical graph for evaluation of the primary endpoint in a clinical trial using the alternative hypothesis, Bayes factor, and confidence interval. Jpn J Biometrics 2023, in press
  2. Tanaka S, Brookhart MA, Fine J. G-estimation of structural nested mean models for interval-censored data using pseudo-observations. Stat Med 2023, in press
  3. Hidaka Y, Imai T, Inaba T, Kagawa T, Omae K, Tanaka S. Efficacy of vonoprazan against bleeding from endoscopic submucosal dissection-induced gastric ulcers under antithrombotic medication: A cross-design synthesis of randomized and observational studies. PLoS One 2021;16(12):e0261703
  4. Tanana S, Langer J, Morton T, Wilkinson K, Tanaka S, Kawasaki R, Moriya T, Horikawa C, Aida R, Araki T, Sone H. Developing a health economic model for Asians with type 2 diabetes based on the Japan Diabetes Complications Study and the Japanese Elderly Diabetes Intervention trial. BMJ Open Diabetes Res Care 2021;9(1):e002177.
  5. Imai T, Tanaka S, Kawakami K. Exploratory assessment of treatment-dependent random-effects distribution using gradient functions. Stat Med 2021;40(2):226-39


Program-specific Professor:Shiro Tanaka
Program-specific Professor:Takashi Omori
Program-specific Assistant Professor:Masatomo Omiya
Program-specific Researcher:Yumi Takagi


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